54092-515 : Intuniv 2 mg 24 Hr Extended Release Tablet

Labeler: Shire Us Manufacturing Inc.
Product Type: Human Prescription Drug
Drug Name:  Intuniv
Dosage Form: Oral Tablet, Extended Release
Application #: NDA022037
Rev. Date: 


Markings: 503;2mg
Shapes:  Oval
Colors:  White
Size (mm): 12
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

503 2mg: (54092-515) Intuniv 2 mg 24 Hr Extended Release Tablet by Shire Us Manufacturing Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 54092-515-02: 100 TABLET, EXTENDED RELEASE IN 1 BOTTLE (54092‑515‑02)
  • 54092-515-03: 7 TABLET, EXTENDED RELEASE IN 1 BOTTLE (54092‑515‑03)

Active Ingredients:

  • Guanfacine Hydrochloride

Dosage Strength:

  • 2 mg

Inactive Ingredients:

  • Hypromellose 2208 (15000 Mpa.s)
  • Lactose Monohydrate
  • Povidones
  • Crospovidone
  • Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)
  • Cellulose, Microcrystalline
  • Glyceryl Dibehenate
  • Fumaric Acid

Pharmaceutical Classes:

  • Adrenergic alpha2-Agonists [MoA]
  • Central alpha-2 Adrenergic Agonist [EPC]

Related Products:

Based on records with the same trade name.
  • 54092-513 Intuniv 1 mg 24 Hr Extended Release Tablet by Shire Us Manufacturing Inc.
  • 54092-517 Intuniv 3 mg 24 Hr Extended Release Tablet by Shire Us Manufacturing Inc.
  • 54092-519 Intuniv 4 mg 24 Hr Extended Release Tablet by Shire Us Manufacturing Inc.
  • 54092-520 Intuniv Kit 7/7 by Shire Us Manufacturing Inc.
  • 64725-0513 Intuniv 1 mg Oral Tablet, Extended Release by Tya Pharmaceuticals
  • 64725-0515 Intuniv 2 mg Oral Tablet, Extended Release by Tya Pharmaceuticals


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